Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

NCT02417402 | Withdrawn

• 1 other identifier: UNICID032015
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.

Conditions

Back Pain

Keywords

back pain; low back pain; chronic low back pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity (Pain NRS)

  Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  5 weeks after randomization

• Disability (24-item Roland Morris Disability Questionnaire)

  Disability will be measured by the 24-item Roland Morris Disability Questionnaire

  5 weeks after randomization

Secondary Outcomes (4)

• Pain intensity (Pain NRS)

  3 and 6 months after randomization

• Disability ( 24-item Roland Morris Disability Questionnaire)

  3 and 6 months after randomization

• Fear Avoidance Beliefs (FABQ)

  5 weeks, 3 months and 6 months after randomization

• Pain Catastrophizing (PCS)

  5 weeks, 3 months and 6 months after randomization

Other Outcomes (2)

• Pain attitudes and beliefs for physiotherapists (PABS.PT)

  Baseline and 5 weeks after randomization

• Adherence to guidelines for physiotherapists (0-100% Low Back Pain Vignettes)

  Baseline and 5 weeks after randomization

Study Arms (2)

Untrained Physical Therapists

ACTIVE COMPARATOR

The patients allocated to the Control group will be treated by physical therapists who did not receive any training about clinical practice guidelines and pain management. These patients will receive the usual care from their physical therapists.

Other: Control

Trained Physical Therapists

EXPERIMENTAL

The patients allocated to the Experimental group will be treated by physical therapists who received training about clinical practice guidelines and pain management.

Other: Trained

Interventions

Control OTHER

The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Also known as: physical therapist education, guidelines implementation

Untrained Physical Therapists

Trained OTHER

The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.

Also known as: physical therapist education, guidelines implementation

Trained Physical Therapists

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.
• physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.

You may not qualify if:

• patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.
• physiotherapists who want to stop the activities for some reason that prevents participation in the study

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

MeSH Terms

Conditions

Back Pain; Low Back Pain

Interventions

Trained Immunity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunity, Innate; Immunity; Immune System Phenomena

Study Officials

• Leonardo OP Costa, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters student

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10